GlobalData estimates that the global Cytomegalovirus (CMV) infections market, comprising the markets of the US, the UK, France, Germany, Italy, Spain and Japan, was worth $685.50m in 2011 and will grow at a Compound Annual Growth Rate (CAGR) of 6.29% over the next eight years to reach $1.12 billion by 2019.

The CMV prophylactic market was estimated to be worth around $423.74m in 2011 and is forecast to grow at a CAGR of 7.79% to $772.01m in 2019. The CMV therapeutic market was estimated to be worth $261.76m in 2011 and is forecast to grow at a CAGR of 3.51% to reach $344.98m in 2019. The key events that are expected to impact the market during the forecast period are:

The genericization of Valcyte in 2013 in the US and its patent expiry in 2015 in Europe in the prophylactic and therapeutic markets

The expiry of Vistides patent in Europe in 2012 in the therapeutic market

The expected launch of Cytotect (CMV hyperimmunoglobulin) in 2015 in Europe in the therapeutic market

The expected launch of TransVax in the US and Europe in 2016 in the prophylactic market

Additional factors that will contribute to growth are the increase of the patient pool, the expected launch of a vaccine due to its novelty and premium price and the increase in the number of Bone Marrow Transplant (BMT) and Solid Organ Transplant (SOT) patients.

Below mentioned figures show a breakdown of prophylactic and therapeutic sales by region.

New Companies Poised to Enter the CMV Prophylactic Market

Roche has a strong presence in the CMV market with Valcyte, which is the only branded product for the treatment of CMV infections. The company is likely to maintain its competitive position until the genericization of Valcyte in 2013 in the US and its patent expiry in 2015 in Europe. During the forecast period the market will experience the launch of a promising vaccine, TransVax, which has shown improved clinical safety and efficacy (Vical, press release, September 13, 2010). The CMV market will see the entrance of new companies that focus on three important strategies: first, companies focusing on novel mechanisms of action beyond DNA polymerase inhibitors; second, companies targeting transplant patients; and third, companies developing prophylactic products (40% of the pipeline products are being developed for CMV prophylaxis).

These strategies are expected to provide a distinct opportunity for pharmaceutical companies to build up their commercial presence in the CMV infections market.

GlobalDatas analysis shows that the CMV development pipeline is strong, with 49 molecules in various stages of clinical development. The late-stage pipeline consists of one First-In-Class (FIC) vaccine, TransVax. TransVax is expected to enter the market within the forecast period and GlobalData expects TransVax to have a significant impact on the market landscape. TransVax is the first plasmid DNA vaccine being developed for CMV prophylaxis in both the US and Europe, and has also received orphan drug designation from the US Food and Drug Administration (FDA). It is expected to raise the barrier to entry for new marketed products, while providing a stiff competitive advantage over those currently on the market.

According to the Key Opinion Leaders (KOLs) interviewed for this report, the pipeline molecules have better efficacy and safety profiles than those currently used and their entrance into the market has the potential to change the current treatment algorithm by addressing existing safety and efficacy needs.

Untapped Market Opportunity with Weak Competition

GlobalDatas analysis shows that current market competition in the CMV market is weak, as Valcyte is the only branded drug for the treatment of CMV. Valcyte is a prodrug of ganciclovir with improved bioavailability, and is considered to be efficacious and safe for the treatment of CMV patients.

Aside from Valcyte, the market is completely dominated by generics, such as ganciclovir and foscarnet. Another drug, CMV-IG, is a biologic that has been available in the US since 1992. Other drugs, such as acyclovir and valacyclovir, are used off-label for CMV infections. All these drugs have low efficacy and safety profiles, leaving an untapped opportunity for companies able to provide better drugs than the existing branded products and generics.

Unmet Need Continues to Challenge the Pipeline Drugs

GlobalDatas analysis indicates that the unmet need in the CMV prophylactics and therapeutics markets is significant, as the currently used treatment options are associated with adverse events such as myelosuppression and renal toxicity. They also have black-box warnings on their labels. Therefore, safety is a major concern in both the prophylactic and therapeutic markets. Efficacy is an unmet need, primarily in the prophylactic market, and viral resistance to the current drugs is a limitation for the therapeutic markets. There remains ample opportunity for new molecules with novel mechanisms of action and new entrants targeting transplant patients as they are at a high risk of developing CMV. This analysis is represented below for the prophylactic and therapeutic markets in below mentioned figures respectively.

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